BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST PICC 26GA, SINGLE LUMEN

    MDR report key: 6016674 · Received October 11, 2016

    Report

    Report Number
    1625425-2016-00064
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    June 16, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER INITIALLY REPORTED, THE DEVICE SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF RETURNED PRODUCT FROM THE CUSTOMER WAS PERFORMED. THE ISSUE WAS CONFIRMED SINCE A SMOOTH SLIT WAS OBSERVED IN THE OVERMOLDED EXTENSION SET WHICH WOULD HAVE ALLOWED THE DEVICE TO LEAK. SINCE THE LEAKAGE WAS INSTANT AND OBVIOUS DURING THE INVESTIGATION, IT WOULD HAVE BEEN EASILY DETECTED DURING THE PRODUCT SET-UP IF THE CATHETER WAS DAMAGED AT THAT POINT; HENCE, THE DAMAGE THAT ALLOWED THE LEAKAGE IS SUSPECTED TO HAVE OCCURRED DURING THE USE OF THE PRODUCT. BASED ON REVIEW OF THE PRODUCT, THE CAUSE WAS MOST LIKELY RELATED TO THE HANDLING OF THE DEVICE IN THE FIELD. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF BREAKAGE AND LEAKAGE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO PRODUCT HAS BEEN RECEIVED FOR EVALUATION, SO THE ISSUE COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS AND INSPECTION RECORDS WAS CONDUCTED AND NO SIMILAR CONCERNS WERE FOUND. AS NO PRODUCT HAS BEEN RETURNED FOR EVALUATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY. ADDITIONALLY, THE INSTRUCTIONS FOR USE INDICATE SEVERAL WAYS USERS CAN MITIGATE THE OCCURRENCE OF LEAKAGE.

    Description of Event or Problem · 1

    THE PICC WAS LEAKING. THE PICC WAS INSERTED ON (B)(6) 2016 AND THE DATE OF EVENT WAS (B)(6)2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670148 FIRST PICC 26GA, SINGLE LUMEN FIRST PICC FOZ ARGON MEDICAL DEVICES INC. 11131667

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention